drugset / Trial / NCT01898442

High Ticagrelor Loading Dose in STEMI

NCT01898442

Phase 2 Completed 52 enrolled University of Florida
RandomizedParallel-groupSingle-blindTreatment

Summary

Ticagrelor is a reversible direct acting P2Y12 antagonist, which has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Ticagrelor is considered a first line therapy to be administered as soon as possible in ACS patients. However, the pharmacodynamic effects of ticagrelor at the recommended 180mg loading dose are delayed in patients with STEMI undergoing primary PCI. The use of higher loading dose regimens of ticagrelor has therefore been advocated. The proposed investigation will have a prospective, randomized, parallel design in which STEMI patients undergoing primary PCI will be randomized to receive three different loading dose of ticagrelor (180 mg, 270 mg and 360 mg). Pharmacodynamic testing will be performed at several time points to test our study hypothesis that a higher loading dose regiment will achieve more promptly enhanced platelet inhibitory effects.

Timeline

Start
2013-09
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ticagrelor Small molecule 180 mg
Comparator Ticagrelor Small molecule 270 mg
Comparator Ticagrelor Small molecule 360 mg